A Message from Kathleen Jaeger: New Year, New Congress, New Hope for Generics

This year is going to be a busy one for
the generic pharmaceutical industry,
with the new Congress making health
care a top priority. As Congress grapples
with controlling escalating health care
costs and increasing access to quality
care, issues impacting our industry will
be front and center in the debate.

Congress has a real opportunity to
increase patient access to safe, effective,
and affordable generics during this session.
Among the many issues on its plate,
the new Congress must reauthorize the
Prescription Drug User Fee Act (PDUFA),
the Pediatric Research Equity Act (PREA),
and the Trade Promotion Act (TPA).

Perhaps the liveliest debate will be
centered on the need for the FDA to create
a clear and effective abbreviated
pathway for the approval of generic biopharmaceuticals.
Biopharmaceuticals are
everyday medicines used to treat conditions
such as heart disease, rheumatoid
arthritis, and cancer, yet their costs are
incredibly high?sometimes as much as
$200,000 per patient per year. Generic
biopharmaceuticals would bring competition
into the health care system,
reduce costs, and increase patient
access. That is why groups like AARP, the
Consumer Federation of America, and
the American Federation of Labor and
Congress of Industrial Organizations are
all supporting legislative efforts to bring
more affordable versions of these medicines
to patients.

PDUFA will also be a topic of much
discussion on Capitol Hill. As part of
PDUFA, the FDA has floated the idea of
requiring that generic drug companies
pay user fees to help fund the agency.
The generic industry is open to talking
about any options that would bring more
affordable medicines to patients faster,
but user fees cannot be discussed in a
vacuum. Paying user fees will not get
drugs to patients faster as long as barriers
such as authorized generics and citizen
petitions exist.

That is why Congress needs to address
the practice of authorized generics.
When the Hatch-Waxman Act was
created, Congress granted a 180-day
period of exclusivity to generic companies
to encourage competition and
ensure that checks and balances are
built into the approval system.
Authorized generics have undermined
congressional intent, however, by devaluing
the 180-day exclusivity period,
which is a critical incentive to bring
generics to market in a timely manner.

Brand companies also use citizen petitions
to stall generic approvals. According
to a Merrill Lynch review of petitions
filed between 2000 and 2005, 76%
were dismissed by the FDA as having no
merit. These needless delays in approvals
cost patients and the health care
system millions of dollars. It is time for
Congress to close these loopholes.

Another measure that must be renewed
is the PREA. The generic industry
strongly supports the goal of the act?to
provide greater access to pediatric medicines?but we need to address the serious
lack of clinical information on the
safe and effective use of these medicines
in children. As it considers renewing
the act, Congress must determine
whether the American health care system
is receiving the best clinical
research and information in return for an
additional 6 months of exclusivity for the
entire family line of the product studied.

Finally, Congress will be debating the
TPA this year. Unfortunately, most free
trade agreements go beyond US law by
providing more intellectual property
rights to the brand industry through
brand patent extensions and market
exclusivity provisions. Even worse,
these free trade agreements do not
include one mandatory generic access
provision. Quite simply, these agreements
can harm patients by delaying
access to generics.

In reauthorizing the TPA, Congress can
put patients back on the playing field. It
can require that the Office of the US
Trade Representative maintains a balance
between pharmaceutical innovation
and access to affordable medicines
from the start of their trade negotiations.
Failure to balance the need for both
pharmaceutical innovation and access
will hurt America's economy, the health
care system, and the availability of
affordable medicines worldwide.

The year 2007 can truly be a watershed
year for Congress?and patients?
to reduce health care costs and increase
access to affordable generic medicines. It
will be a busy session, but Congress has
a real opportunity to remove barriers to
accessing quality care and put control
and choice in the hands of patients.